Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06011018
Collaborator
(none)
72
1
3
45.2
1.6

Study Details

Study Description

Brief Summary

This study aims to compare the effects of mirror therapy combined with either neuromuscular electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function recovery. The study also explores the relationship between patients' cortical excitability and motor function improvement.

Condition or Disease Intervention/Treatment Phase
  • Other: Mirror Therapy
  • Other: Mirror Therapy + Electrical Stimulation
  • Other: Mirror Therapy + Binaural Beat
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants were randomly assigned treatment groups: Mirror Therapy Mirror Therapy + Electrical Stimulation Mirror Therapy + Binaural BeatParticipants were randomly assigned treatment groups:Mirror Therapy Mirror Therapy + Electrical Stimulation Mirror Therapy + Binaural Beat
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
Actual Study Start Date :
Oct 25, 2022
Anticipated Primary Completion Date :
Jul 31, 2026
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirror therapy

Other: Mirror Therapy
Sitting, mirror place at the midline between the legs. Unaffected leg is placed in front of the mirror and perform ankle dorsiflexion exercises. Duration: 5 seconds, Rest: 5 seconds

Experimental: Mirror Therapy + Electrical Stimulation

Other: Mirror Therapy + Electrical Stimulation
Same as the mirror therapy protocol. Affected leg: electrical stimulation on tibialis anterior muscle. Frequency: 35 Hz, Pulse width: 250µs, Duration: 5 seconds, Rest: 5 seconds.

Experimental: Mirror Therapy + Binaural Beat

Other: Mirror Therapy + Binaural Beat
Same as the mirror therapy protocol. Listen to music (mozart's clarinex concerto in A major K622), with Alpha (8Hz) binaural beat stimulation

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer assessment, lower extremity [10minutes]

    The Fugl-Meyer Assessment for lower extremity is a scale used to evaluate motor and functional recovery in patients with conditions like stroke. It measures muscle strength, movement control, coordination, and balance. Scores range from 0 (no movement) to 34 (full recovery). Higher scores indicate better recovery.

Secondary Outcome Measures

  1. Modified ashworth scale [5minutes]

    The Modified Ashworth Scale assesses muscle spasticity in conditions like stroke or cerebral palsy. Scores range from 0 to 4 or 5, indicating the severity of muscle resistance during passive movement. Higher scores mean more severe spasticity. It guides treatment and tracks progress.

  2. Timed up and go test [5minutes]

    The Timed Up and Go (TUG) test assesses mobility by measuring the time it takes for someone to stand, walk a short distance, turn, and sit back down. Faster times suggest better mobility, while longer times may indicate mobility limitations or fall risk. It's a useful tool to evaluate functional capacity and guide interventions for improved mobility.

  3. The postural assessment scale for stroke patients [10 minutes]

    Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.

  4. Barthel index [5minutes]

    The Barthel Index assesses a person's ability to independently perform daily activities. Scores range from 0 to 100, with higher scores indicating greater independence.

Other Outcome Measures

  1. Electroencephalography [20minutes]

    Electroencephalography is used obtain power data of total μ (8-12Hz), lower μ (8-10Hz), and upper μ (10-12Hz). μ suppression→ a negative value (<0) indicates inhibition of μ waves, indicating activation in the motor cortex(Bae et al., 2012).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. First occurrence of stroke≧ 6 months

  2. Mini-mental state examination≧24

  3. Modified Ashworth's scale of ankle muscle ≦3

  4. Sit independently≧30 mins

  5. Brunnstrom stage ≧3

  6. Aged between 20 and 80 years

Exclusion Criteria:
  1. Speech impairment

  2. Hearing impairment

  3. Visual impairment

  4. Other orthopedic diseases or nerve damage

  5. Complete sensory impairment

  6. Pacemaker or metal implants

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Medical University, Department of Physical Therapy Kaohsiung Taiwan 807

Sponsors and Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Chair: LIN JAU HONG, Ph.D., Kaohsiung Medical University,department of Physical Therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT06011018
Other Study ID Numbers:
  • KMUHIRB-F(II)-20220175
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023